February 28 2020

OMALIZUMAB

List of brands containing omalizumab   

This page contains list of brands of authorized pharmaceutical specialties of the active ingredient omalizumab in the countries listed below:

Australia] [ Brazil] [ Canada] [ France] [ Germany] [ India] [ Italy] [ Japan] [ Mexico] [ Pakistan] [ Puerto Rico] [ Spain] [ Turkey] [ United Kingdom] [ U.S.A]

Given the nature of the pharmaceutical market, some specialties may be unavailable, have been removed from the pharmaceutical market or have changed its name. So that, in no case can take decisions based on the information contained on the page. MEDIZZINE is not responsible for any damage arising from the information provided, which may be incomplete or outdated.

Indications and usage     

Omalizumab is used to prevent your asthma getting worse and control your asthma symptoms when given in addition to your other asthma medication.

Omalizumab is used to control symptoms of severe allergic asthma in adults or adolescents (over 12 years) whose symptoms are not adequately controlled with high doses of steroids or inhaled beta agonists.

The drug omalizumab works by blocking a substance called immunoglobulin E (IgE) which is produced by your body. IgE plays a key role in causing allergic asthma. Your doctor will determine the amount of IgE in your blood before giving you omalizumab injections.

Medizzine recommends consulting your doctor if you are unsure (or you do not know) why you have been given omalizumab.

Other ingredients of available commercial presentations:

Besides the active ingredient omalizumab, the other components are sucrose, histidine, histidine hydrochloride monohydrate, and polysorbate 20.

The package also contains a vial with 2 ml of water for injections which is used to dissolve the powder before injection.

The active substance omalizumab is a white powder in a small glass vial together with an ampoule containing 2 ml of water for injections. The powder is reconstituted with water before being injected by the clinician. Each vial provides 150 mg omalizumab.

Warning:

The composition of the various presentations may vary from one country to another. We recommend you consult the information provided by your local supplier.

Important information     

If you are diabetic or have been told by your doctor that you have an intolerance to some sugars, tell your doctor before using omalizumab, as it contains sucrose.

Before taking the drug     

Do not use omalizumab

If you are allergic (hypersensitive) to omalizumab or any of the other ingredients of the medicinal product prescribed to you. If you think may be allergic, ask your doctor.

Allergy symptoms may include:

- Asthma attacks with shortness of breath, audible wheezing or rapid breathing.
- More or less sudden swelling of the face, lips, tongue or elsewhere in the body. It is especially critical if it affects the vocal cords.
- Hives, itching, rash
- Anaphylactic shock (loss of consciousness, paleness, sweating, etc.).

Check with your doctor before receiving an injection.

Take special care with

Do not use omalizumab to treat acute asthma symptoms, as is a sudden asthma attack. To do this, you will be given a different drug.

Take care with allergic reactions to omalizumab. This active ingredient contains a protein and proteins can cause serious allergic reactions in some people.

Signs of an allergic reaction include rash, difficulty breathing, swelling or feeling faint.

If you suffer an allergic reaction following administration of omalizumab, contact your doctor as soon as possible.

Do not use omalizumab to prevent or treat other allergy-type conditions, such as:

- Sudden allergic reactions
- Hyperimmunoglobulinaemia E syndrome (an inherited immune disorder)
- Aspergillosis (a lung disease caused by a fungus)
- Food allergy, allergic skin rash or hay fever.

This drug does not will harm you, but you may need other different medicines to treat these conditions.

Parasitic infections:

Tell your doctor if you live in a region where parasite infections are frequent or if you travel to one of these regions. Omalizumab may lower your resistance to such infections.

Tell your doctor if you are taking a treatment against a parasite infection. Omalizumab may decrease the effectiveness of treatment.

Remember that your doctor has prescribed this medicine only for you. Never give it to someone else.

If in doubt, consult your doctor.

Taking other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including herbal products or drugs obtained without a prescription.

Especially, tell your doctor or pharmacist if you are taking:

Omalizumab can be used together with inhaled corticosteroids and other medicines for allergic asthma, but nevertheless, it is important that you tell your doctor if you are taking these medications before you are given omalizumab.

You will need to continue taking your current asthma medication during treatment with omalizumab. Do not stop taking any asthma medication without consulting your doctor.

Consult your doctor or pharmacist before taking any medicine.

Special physiological situations

Pregnancy and lactation

always consult your doctor or pharmacist before taking any medicine during pregnancy or lactation.

Pregnancy

Before starting treatment with omalizumab, tell your doctor if you are pregnant or intend to become pregnant. Your doctor will discuss with you the benefits and potential risks of administering this drug during pregnancy.

Tell your doctor immediately if you become pregnant while being treated with omalizumab.

Lactation

Before using omalizumab get advice from your doctor if you are breast-feeding or planning to do it. Omalizumab may pass to the baby through breast milk.

Omalizumab in children and adolescents

Do not give omalizumab to children under 12 years of age, since its effect is not known in these patients.

Use in elderly

Omalizumab may be administered to people over 65 years old. There is no evidence to suggest that elderly patients require special precautions when treated with omalizumab, although experience is still limited.

Patients with kidney or liver problems

If you have liver or kidney problems, talk to your doctor about using omalizumab.

Driving and using machines

Omalizumab may cause some people feel dizzy, sleepy or faint, although this is rare. Be careful: make sure you are not affected before driving or operating machinery.

How to use omalizumab     

Follow carefully instructions of use of omalizumab provided from your doctor. Consult your doctor or pharmacist when in doubt. Follow the instructions of the physician in preference to those given in this website, which may be different. Ask your doctor to explain any aspect that you do not understand, contained in the instruction leaflet that comes with the medicine.

Your doctor will administer omalizumab as an injection under the skin.

Before starting treatment with omalizumab, your doctor will perform a blood test to determine the concentration of IgE. Your doctor will estimate the omalizumab amount you need and frequency of administration. This will depend on your body weight and the blood IgE level you have.

How much to administer?

You will receive 1 to 3 injections every two to four weeks.

You will need to continue taking your current asthma medication during treatment with omalizumab. Do not stop any asthma medication without consulting your doctor.

You may notice no improvement in your asthma after beginning treatment with omalizumab. Usually, you should wait several weeks until the drug achieves its full effect.

If you think the effect of the medicine is too strong or too weak, consult your doctor.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

While you take omalizumab     

If a doctor prescribes another medicine, tell you are taking omalizumab.

Check with your doctor regularly developments of disorder that motivates the use of omalizumab. Maybe there is some reason that prevented you properly receive the indicated doses and induce your doctor to erroneous conclusions about treatment.

Do not restart treatment with omalizumab at your own risk without first talking to your doctor, nor encourage its use by another person, even if have the same symptoms you have. Nor is it advisable to interrupt or reduce the dose without considering the opinion of your doctor.

If you feel unwell during treatment with omalizumab, immediately consult your doctor.

If you take more than you should:

Check with your doctor if you accidentally get more omalizumab than prescribed.

If you forget to take omalizumab

If you forget to use omalizumab use it as soon as you remember or contact your doctor. Do not double the dose to make up the missed dose. Check with your doctor.

If you stop taking omalizumab

Interrupting or ending the omalizumab treatment may cause a recurrence of asthma symptoms.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Side Effects of omalizumab     

Like all medicines, omalizumab can cause side effects although not everybody gets them.

The frequency of side effects is classified into:

Very common: affect 1 out of 1-10 patients
Common: affect 1 out of 10-100 patients
Uncommon: affect 1 out of 100-1.000 patients
Rare: affect 1 out of 1.000-10.000 patients
Very Rare: affect less than 1 in 10,000 patients
Incidence not known: Can not be established the true incidence from the available data

Adverse effects caused by omalizumab are usually mild to moderate but can occasionally be serious.

Serious side effects include:

Sudden severe allergic reactions (rare).

If you notice sudden signs of allergy, such as hives, itching or rash, swelling of the face, lips, tongue and other parts of the body (angioedema), fast heart rate, dizziness and light-headedness, wheezing or breathlessness, or any other new symptoms, tell your doctor or nurse immediately.

Joint symptoms such as numbness, tingling in the arms and legs, lumps or raised patches of the skin, weakness and fatigue, loss of appetite and weight loss (signs of so-called "Churg-Strauss syndrome").

Low blood platelet count with symptoms such as bleeding or bruising that occurs more easily than normal.

immediately tell your doctor or nurse if any of the above-mentioned effects.

Other side effects include:

Common side effects

- Headache
- reactions at the injection site including pain, swelling, itching and redness.

Uncommon side effects

- feeling dizzy, sleepy or tired
- tingling or numbness in the hands or feet
- fainting, low blood pressure while sitting or standing (postural hypotension), flushing
- A sore throat, coughing, acute breathing problems
- Feeling sick (nausea), diarrhea, indigestion
- Itching, hives, rash, an increased sensitivity of the skin to sunlight
- weight gain
- flu-like symptoms, joint pain, muscle pain, and joint swelling
- Hair loss

Tell your doctor if any of these side effects affect you severely.

This list does not include all adverse reactions associated with the use of omalizumab, both well established as those that are under consideration or confirmation. In case you feel unwell, should immediately consult with the doctor who prescribed this medicine.

If you notice any side effects not listed in this website or in the leaflet accompanying the package, ask your doctor or pharmacist.

If any of the side effects gets serious, tell your doctor or pharmacist.

List of brands containing omalizumab     

This page contains list of brands of authorized pharmaceutical specialties of the active principle omalizumab in the countries listed below:

Australia] [ Brazil] [ Canada] [ France] [ Germany] [ India] [ Italy] [ Japan] [ Mexico] [ Pakistan] [ Puerto Rico] [ Spain] [ Turkey] [ United Kingdom] [ U.S.A]

Given the nature of the pharmaceutical market, some specialties may be unavailable, have been removed from the pharmaceutical market or have changed its name. So that, in no case can take decisions based on the information contained on the page. MEDIZZINE is not responsible for any damage arising from the information provided, which may be incomplete or outdated.

Warning:

With exceptions expressly indicated, these lists do not include active principle associations with other drugs or clinical use containers.

Australia:     

XOLAIR 150 mg, injectable solution

Brazil:     

XOLAIR 150 mg, injectable solution

Canada:     

XOLAIR 150 mg, injectable solution

France:     

XOLAIR 75 mg, injectable solution
XOLAIR 150 mg, injectable solution

Germany:     

XOLAIR 75 mg, injectable solution
XOLAIR 150 mg, injectable solution

India:     

N/A

Italy:     

XOLAIR 150 mg, injectable solution

Japan:     

XOLAIR 150 mg, injectable solution

Mexico:     

XOLAIR 150 mg, injectable solution

Pakistan:     

XOLAIR 150 mg, injectable solution

Spain:     

XOLAIR 150 mg, injectable solution

Turkey:     

XOLAIR 150 mg, injectable solution

United Kingdom:     

XOLAIR 75 mg, injectable solution
XOLAIR 150 mg, injectable solution

U.S.A. and Puerto Rico:     

XOLAIR 150 mg, injectable solution

Page updated: October 05, 2008.